Global bioethics blog

Promoting reflection on bioethics and research ethics issues in Sub-Saharan Africa

Thursday, November 20, 2014

Ebola and the ethics of research design

A couple of recent articles stimulated my interest on the ethics of conducting ebola research, particularly with those conducted in low-resource settings and having a randomised controlled design. It interested me enough to write a letter to JAMA, where it got bounced. I thought about submitting to Lancet, but hip replacement surgery got in my way: just too much work. So it goes. Part of what is fascinating about the topic are the underlying issues regarding whether doing anything other than the 'gold standard' of clinical trials is justified. I am diverting this piece to Global Bioethics Blog just in case a reader finds something of value in it.

Two recent commentaries in this journal argue
for and against conducting randomized controlled trials (RCTs) of new Ebola
drugs during the current epidemic.[i][ii]
Those in favor argue that only RCTs can deliver the evidence required to treat
future Ebola patients in ways superior to the current standard of care, which
is largely palliative. Other observers hold a similar view.[iii]
Those opposed to RCTs in this context argue that if patients were randomized to
study arms of either (a) a new drug or (b) the baseline 70% mortality rate for
Ebola, such a trial would not possess equipoise, because (arguably) the
intervention arm would likely provide at least some benefit. In addition,
opponents argue that local communities ravaged by Ebola – whose trust in
authority, including medical authority, has been profoundly shaken -- are
unlikely to accept a randomized controlled trial design.They therefore advocate for experimental
drugs to be offered to patients within non-RCT research designs, even if they
have not been tested by the ‘gold standard’ methodology.

On the face of it, this seems like a
conflict between advocates of evidence-based medicine and those who
understandably, but misguidedly, want to provide less-than-well-tested drugs to
the sick as soon as possible. But while the former position seems rational and
impartial, history reveals some unsettling patterns. When the HIV epidemic was
raging in the United States decades ago, advocacy groups mobilized aggressively
for expedited access to new experimental treatments, bypassing the full FDA approval
process.[iv]
The alternative then, for many AIDS patients, was death. Current policies
surrounding ‘compassionate use’ were borne out of this experience. This raises
the question: is it easier to take a hard utilitarian position on the need for
RCTs when it is someone else’s epidemic?

The faith placed in scientific knowledge to
resolve deep social problems is also part of an old pattern. When health crises
occur in developing countries, international efforts often focus on fast-tracking
biomedical interventions rather than also engaging the social, economic, and
political factors contributing to emerging infections. Citizens of low-resource
countries have every right to be skeptical here. Drugs to prevent mother-to-child
HIV transmission were tested and developed two decades ago; only 57% of women
in sub-Saharan Africa currently have access to it.[v]
The same (or worse) can be said for a host of other diseases. Access to new
Ebola drugs, should they be successfully developed, will likely to follow the
same trajectory. Again, the argument that we should only encourage RCT trial
designs for new Ebola drugs, out of scientific concern for the evidence base,
may be more compelling in places other than Monrovia.